FR2850564A1 - Apparatus for the impromptu delivery of a sterile fluid, and especially a sterile gas for use during ophthalmic surgery, has a cartridge linked to a syringe through a unit to sterilize the gas by filtration - Google Patents

Abstract

The apparatus for an impromptu preparation of an individual quantity of a sterile fluid has a rigid cartridge (3) containing the fluid. A syringe (4) has a piston sliding within a cylinder, and an axial outflow opening (41). A flushing/sterilizing unit (5,6) is fitted in the flow path between the cartridge and the syringe, to sterilize the fluid by filtration.

Description

APPARATUS AND METHOD FOR EXTEMPORANEOUSLY PREPARING A QUANTITY

INDIVIDUAL STERILE FLUID

  The invention relates to a device and a method for the extemporaneous preparation of an individual quantity of sterile treatment fluid for administration to a patient (human or animal).

  Certain therapeutic or surgical applications require the administration of a sterile fluid, said treatment fluid, in particular a gas, for example air or a fluorocarbon gas (CF4, C2F6, C3F8, ...), SF6, N2, C02, ... For example, certain ophthalmic surgical procedures require the topical administration of such a perfectly sterile neutral treatment gas into the ocular cavity.

  The general problem which therefore arises in this context is that of making available to the practitioner an individual quantity (that is to say intended for a single patient) of this fluid in the perfectly sterile state, and in conditions appropriate to the intended administration.

  Until now, in practice, the quantities of treatment fluid have been prepared by filling an administration syringe from a large-volume gas cylinder under high pressure and via a pressure reducer and a sterilization device by filtration. . However, these large bottles and the gas they contain cannot be sterilized or maintained in a sterile state under satisfactory conditions. The passage of the syringe from the non-sterile filling site to the bottle to the sterile site of use (for example surgical block) requires many manipulations and precautions, entails risks of contamination, and does not make it possible to provide a " ad hoc traceability of each individual amount of treatment fluid administered to each patient.

  The invention therefore aims to overcome these drawbacks by proposing a device allowing the extemporaneous preparation, on the site of use, of an individual quantity of treatment fluid, in particular treatment gas - sterile, simple and reliable to use, avoiding any leakage of fluid during assembly and preparation, in particular completely hermetic when filling the syringe, and any risk of rupture of the asepsis, and which can itself be completely sterilized without risk, in particular with oxide ethylene.

  The invention also aims to propose such a device which makes it possible to ensure monitoring ("traceability") of the doses of fluid administered.

  The invention also aims to provide such a device which is simple and inexpensive to manufacture, and includes only a reduced number of parts.

  To do this, the invention relates to a device for the extemporaneous preparation of an individual quantity of sterile treatment fluid for administration to a patient, comprising: - a reservoir containing a quantity of treatment fluid, - a syringe d administration of a dose of treatment fluid, comprising a piston sliding in a cylinder provided with a through axial end, - a connection / sterilization device adapted to allow the assembly and the hermetic connection of the reservoir, the syringe and of the sterilization device for filling the syringe, this connection / sterilization device comprising a filtration sterilization device comprising an airtight enclosed casing provided with a fluid inlet, and a fluid outlet delivering sterile fluid towards the syringe, this casing containing a filter capable of sterilizing the treatment fluid flowing between the inlet and the outlet, characterized in that: - the reservoir is formed of a rigid cartridge containing an individual quantity of pressurized treatment fluid, provided with an outlet valve 25 resiliently biased axially outward in the closed position and being able to be pushed axially inwards with a view to opening it for the release of the treatment fluid, - the cylinder of the syringe is adapted to be able to contain the amount of treatment fluid which can be released by the cartridge at atmospheric pressure.

  The fact of using a rigid cartridge in particular makes it possible in practice to achieve perfect sterilization of the entire device. Indeed, such a rigid cartridge can in particular be made of metallic material forming a perfect barrier to the sterilization fluid such as ethylene oxide. In addition, such a rigid cartridge can contain the treatment fluid without any risk of contamination of this treatment fluid. Furthermore, the rigid pressurized cartridge only contains an individual quantity of treatment fluid, that is to say a single dose, which in particular makes it possible to avoid any risk of contamination by pathogenic microorganisms which may result from use. multiple of the same fluid reservoir. In addition, with individual quantity and single use cartridges, it is possible to monitor the quantities of fluid administered ("traceability").

  Advantageously and according to the invention, the connection / sterilization device is suitable for carrying out an axial assembly of the syringe, of this connection / sterilization device, and of the cartridge valve, and to allow the filling of the syringe, without leakage of treatment fluid, by simple axial bringing together of the syringe and the cartridge. Therefore, the handling of the device according to the invention both for assembly and for filling the syringe is particularly simple and ergonomic.

  In addition, advantageously and according to the invention, the connection / sterilization device comprises a connection portion to the valve of the cartridge, and this connection portion and this valve are adapted so that: - in a first stroke of relative axial approximation , a hermetic connection can be made between them, without actuation of the valve of the cartridge which remains closed, - in a second subsequent axial approximation stroke beyond the first stroke, the valve is open.

  Such a device makes it possible in particular to avoid any risk of fluid leakage at the very moment of assembly and connection, since the valve remains completely closed as long as the connection is not completely hermetic.

  Advantageously and according to the invention, the valve of the cartridge 5 is a female valve provided with a dispensing orifice, a peripheral seal, and an actuating cavity adapted to receive one end of a bi-functional nozzle for actuating the valve and ejecting the treatment fluid, and said connection portion of the connection / sterilization device forms a bi-functional nozzle compatible with the female valve of the cartridge.

  Such an embodiment is particularly simple and advantageous, inexpensive, convenient and reliable in use. It should be noted in this regard that the use of a male outlet valve for the cartridge is not completely excluded, but, unlike a female valve, would cause assembly difficulties, and would risk particular to cause an untimely actuation of the valve, that is to say an untimely opening of this valve, at the very moment when the assembly is carried out. In fact, in the alternative embodiment where it is desired to use a male outlet valve, it would be advisable to provide a push diffuser button on this male outlet valve, this push diffuser button being provided with a connection, notably frustoconical, of radial connection to the connection / sterilization device.

  Advantageously and according to the invention, in the embodiment where the valve is a female valve, the connection / sterilization device comprises an upstream hermetic connection device having, on one side, said bi-functional nozzle compatible with the female valve of the cartridge, and on the other side, a connection compatible with the inlet of the sterilization device by filtration.

  Advantageously and according to the invention, said connection of the upstream hermetic connection device is a frustoconical connection - notably standardized (NF EN 1615) of Luer type (-, for example female, combined with a frustoconical connection - especially standardized of Luer type @ - for example male, formed by the inlet of the sterilization device by filtration.

  Advantageously and according to the invention, the outlet of the sterilization device by filtration is adapted to be able to be connected directly - without intermediate connection - to the axial end of the administration syringe.

  Advantageously and according to the invention, the outlet of the sterilization device by filtration is a female frustoconical connection, in particular a normalized Luer type connection) - combined with a male frustoconical connection - especially normalized Luere type - formed by the axial end of the administration syringe.

  Alternatively, it is nevertheless possible to provide a downstream connecting device intended to be interposed between the filtration sterilization device and the axial end of the administration syringe. Such a downstream connection device can for example be provided with a stopcock making it possible in particular to avoid any entry or exit of fluid out of the syringe during the positioning of the administration needle on the syringe.

  Advantageously and according to the invention, said functional bi15 nozzle comprises an at least substantially cylindrical external wall having an elastic locking allowance extending in peripheral radial projection relative to this external wall and adapted to elastically disappear when the peripheral seal passes. of the cartridge valve. Advantageously and according to the invention, the additional thickness is adapted to prevent any untimely dissociation of the nozzle with respect to the valve, in particular during filling of the syringe.

  Advantageously and according to the invention, the additional thickness is of generally frustoconical shape.

  Furthermore, advantageously and according to the invention, the cartridge comprises a flexible internal pocket containing said individual quantity of pressurized treatment fluid connected to the outlet valve, and outside the pocket (but inside the cartridge), an amount of pusher gas suitable for pressurizing the treatment fluid contained in the bag. Advantageously and according to the invention, the pusher gas is of the same nature as the treatment fluid, in particular identical to the treatment fluid when the latter is a treatment gas. Thus, the pusher gas does not in itself constitute a risk of toxicity or contamination for the patient.

  Advantageously and according to the invention, the pressure of the treatment fluid in the cartridge is slightly higher than atmospheric pressure, so as to avoid any accident and any untimely leak during assembly and filling of the syringe. Advantageously and according to the invention, the quantity of pusher gas is adapted to maintain in the pocket an overpressure of treatment fluid of less than 2000 hPa, in particular of the order of 600 to 1800 hPa. In this way, it is not necessary to provide a regulator or a pressure gauge, or a stop valve 10 for filling the syringe from the cartridge.

  Furthermore, advantageously and according to the invention, the cartridge comprises a volume of treatment fluid of between 10 ml and 100 ml - in particular of the order of 40 ml -, less than the total capacity of the syringe.

  In addition, advantageously and according to the invention, the cartridge 15 comprises a seal for closing the orifice of the female valve adapted to prevent any penetration of sterilization fluid into the valve and the cartridge, and to be able to be broken by introduction of the bi-functional nozzle in the valve orifice. This seal, which comprises for example an aluminum film, makes it possible to avoid any contamination of the treatment fluid and / or of the valve of the cartridge 20 by the sterilization fluid - in particular ethylene oxide -.

  Advantageously, the device according to the invention further comprises a sterile needle capable of being connected to the end of the syringe for the administration of the treatment fluid to the patient; and a label, in particular in the form of a bracelet, intended to be associated with the patient, which may bear a reference identifying the cartridge of treatment fluid used. This bracelet is used to indicate to the nursing staff that the patient has been treated with the treatment fluid, so that appropriate precautions can be taken for subsequent care and treatment. This is particularly advantageous and important in the case of a process gas.

  The device according to the invention also comprises an external sterile packaging envelope containing all of the constituent elements of the device in the sterile state. It therefore comes in a single sterile packaged package ready for use at the site of administration.

  The invention extends to a method for the extemporaneous preparation of an individual quantity of sterile treatment fluid for administration to a patient, using a device according to the invention.

  Advantageously and according to the invention, the syringe, the connection / sterilization device and the cartridge valve are assembled axially, so as to form a communication hermetically isolated from the outside, then the syringe and the cartridge so as to open the valve and introduce into the syringe a predetermined dose of sterile treatment fluid, by pressure balancing. The treatment fluid can then be used pure or diluted.

  In the latter case, when the treatment fluid is a treatment gas, the treatment fluid is diluted in the syringe by: pushing the plunger to eject the excess treatment fluid from the syringe, - pulling the plunger to introduce in the syringe a quantity of atmospheric air for dilution via the sterilization device by filtration.

  Advantageously and according to the invention, the sterilization device by filtration is then separated from the syringe to which an administration needle is connected. The syringe can then be used with the needle for administering the treatment fluid to the patient.

  The device and method according to the invention are particularly simple, reliable, and guarantee great safety in use, without risk of leakage, accident or contamination. They also make it possible to guarantee the monitoring of the doses of fluid administered ("traceability").

  The invention also relates to a device and a method characterized in combination by all or some of the characteristics mentioned above or below.

  Other objects, characteristics and advantages of the invention will appear on reading the following description of one of its embodiments given by way of non-limiting example, and which refers to the appended figures in which: Figure 1 is a perspective diagram illustrating an example of a device according to the invention, - Figure 2 is a sectional view of an exemplary embodiment of a valve for a cartridge of treatment fluid of a device according to the invention before use, - Figure 3 is a view similar to Figure 2 illustrating the valve during filling of the syringe, - Figures 4 to 8 are schematic sectional views respectively illustrating different steps of a method according to the invention .

  The device 1 according to the invention represented in FIG. 1 is presented in the sterile conditioned state, ready for use, and comprises: - an external envelope 2 of sterile packaging defining a closed hermetic enclosure enclosing the various constituent elements of the device 1, namely: a rigid cartridge 3 serving as a container containing an individual quantity of treatment fluid - in particular a treatment gas - under pressure, 25. an administration syringe 4, a device 5 for sterilization by filtration,. an upstream hermetic connection device 6 intended to be interposed between the filtration sterilization device 5 and the cartridge 3,. an administration needle 7, a bracelet 8 intended to be worn by the patient. All of these components are disposable, single use.

  The cartridge 3 comprises an external metal housing 9 5 -notably aluminum or tinplate- rigid defining an end opening closed by an outlet valve 10 carrying a pocket 1 1, for example of the type sold under the brand EPSPRAY SYSTEMO by the company EP SPRAY SYSTEM SA (Neuchâtel, Switzerland), extending inside the housing 9 and associated with its internal enclosure in fluid communication with the valve 10.

  The valve 10 comprises a rigid metallic closure wall 12 fixed to the end of the housing 9 hermetically by means of a seal 13, and having a central circular orifice 14 for dispensing. A rigid sleeve 15 is fixed under the orifice 14 by crimping this sleeve 15 by a narrowed portion of the wall 12 tightened against an external shoulder 16 for crimping the sleeve 15. A peripheral seal 17 is interposed between the end of the sleeve 15 and the wall portion 12 defining the dispensing orifice 14. This seal 17 has a circular lumen 25 under the orifice 14.

  The sleeve 15 defines at its upper end a bore 18 of larger diameter than the orifice 14 and that the internal diameter of the circular opening 25 defined by the seal 17 which is itself slightly smaller than that of the dispensing orifice 14. This bore 18 contains a valve 19 having an upper closure edge 20 in the form of a circular crown adapted to come into contact with the lower wall of the seal 17 extending opposite the bore 18. The valve 19 is biased elastically axially against the seal 17 by a compression spring 21 disposed inside the bore 18, and bearing on one side against an internal shoulder 22 of the bore 18 and, on the other side, against a shoulder 23 of the external wall of the valve 19.

  The external wall of the valve 19 has a smaller radial dimension than that of the bore 18 at the closure edge 20, so that a clearance is provided radially between the closure edge 20 and the bore 18. This clearance allows the passage of the fluid around the valve 19 and then between the seal 17 and the shutter edge 5 when the valve 19 is pushed down against the spring 21.

  The valve 19 further comprises an actuating cavity 24 in the form of a pyramid trunk adapted to receive the axial end 34 symmetrical of revolution of a rigid bi-functional nozzle 26 for ejecting the treatment and actuating fluid. of valve 10. This nozzle 26 is formed of a hollow tubular portion symmetrical of revolution. It is bifunctional in the sense that it can exercise a first function consisting in actuating the valve 19 and the valve 10 to open it, and a second function consisting in carrying out an ejection passage of the treatment fluid out of the valve 10 and of the cartridge 3. The actuation cavity 24 has an upper end opening 27 whose radial dimensions are slightly greater than those of the opening 25 of the seal 17 and those of the dispensing orifice 14 . The actuation cavity 24 is closed at its lower end by a bottom 28 of the valve 19, so that no passage of treatment fluid is possible through the valve 19 when the latter is pushed back 20 by the spring 21 with its closing edge 20 against the seal 17 sealing. The pyramidal cavity 24 is of polygonal cross section, for example triangular, so that a passage of treatment fluid is necessarily formed between the internal wall of this cavity 24 and the axial end 34 symmetrical of revolution of the inserted nozzle 26 in this cavity 24.

  The pocket 11 is hermetically fixed, for example by gluing, against the external wall of the sleeve 15, the bore 18 of which opens out inside the pocket 11. This pocket 11 therefore defines, on the one hand, an internal enclosure 29 which contains the treatment fluid and is in communication with the bore 18 up to the valve 19, and, on the other hand, between this pocket 11 and the wall of the housing 9, an intermediate enclosure 30 containing an appropriate quantity pressurized pusher gas. This pusher gas is preferably a physiologically acceptable gas, compatible with the treatment fluid and with the sterilization process, in particular with ethylene oxide. In this way, on the one hand, any complication in the event of accidental diffusion of the pusher gas into the treatment fluid is avoided, and, on the other hand, any risk of accident during the sterilization step at ethylene oxide.

  Advantageously, in a device according to the invention, the pusher gas is of the same nature as the treatment fluid. In particular, the inventor has found that most of the treatment gases can in practice act as pusher gases. This is in particular the case of fluorocarbon gases such as CF4. The quantity of pusher gas contained in the intermediate enclosure 30 is adapted to pressurize the treatment fluid in the enclosure 29 of the bag 11 at an appropriate relative pressure. Advantageously and according to the invention, the quantity of pusher gas is adapted to maintain in the pocket 11 an overpressure of treatment fluid 15 of less than 2,000 hPa-notably of the order of 600 to 1,800 hPa. This overpressure is of relatively low value but sufficient for spontaneous filling of the syringe (the piston being m by the pressure of the treatment fluid) as explained below, without regulator or stopcock. The bag 11 is moreover of a volume corresponding to that of the individual quantity of treatment fluid to be delivered by the cartridge 3. In practice, this volume of treatment fluid is typically between 10 ml and 100 ml, in particular l 'order of 40ml-.

  The orifice 14 for distributing the wall 12 for closing the valve 10 is advantageously closed hermetically before use by a cover 31 for hermetically closing this orifice 14. This cover 31 is hermetically bonded 25 to the outside of the wall 12 and is adapted to prevent any penetration of sterilization fluid into the valve 10, in particular into the cavity 24 and into the bore 18, that is to say in the pocket 11. To do this, in the case in particular o uses ethylene oxide as sterilization gas, the cover 31 comprises at least one aluminum foil acting as a hermetic barrier to ethylene oxide. This cover 31 is nevertheless sufficiently fine to be able to be broken by introducing the bi-functional nozzle 26 into the orifice 14 of the valve 10 for the purpose of filling a syringe. The cover 31 is made of non-elastic material so as to allow easy breaking of this cover 31 by the nozzle 26. It must nevertheless be thick enough to offer a resistance which requires the exercise of an axial force beyond d 'a threshold value to cause its rupture. In this way, any involuntary rupture of the cover 31, and therefore any untimely actuation of the valve 10, is avoided.

  Before use, the cartridge 3 appears as shown in FIG. 2 and therefore contains an individual quantity of treatment fluid inside the enclosure 29 of the bag 11 under a relative pressure of the order of 600 to 1,800 hPa , maintained by an identical relative pressure of pusher gas in the intermediate enclosure 30.

  The upstream hermetic connection device 6 is a connection made of synthetic material which can be sterilized forming on the one hand said functional nozzle 26 bi15 compatible with the female valve 10 of the cartridge 3, and on the other side, a frustoconical connection 36-notably standard Luer type (- compatible with the fluid inlet 33 of the filtration sterilization device S. This connection 6 is hollow so as to form an axial fluid passage through the nozzle 26 and over its entire length.

  The bi-functional nozzle 26 formed by this fitting 6 must have dimensions compatible with those of the valve 10, that is to say with those of the light distribution orifice 14, of the seal. 17, and of the actuation cavity 24 of the valve 19. It must be rigid enough to allow breaking the cover 31 and pushing the valve 19 against the spring 21 axially. 25 As can be seen in FIG. 3, the nozzle 26 has an external cylindrical wall 32 of revolution with a diameter slightly greater than that of the circular opening 25 of the seal 17, so that when this nozzle 26 is introduced into the orifice 14, the seal 17 comes into contact with a portion of this external wall 32 while ensuring the sealing of the treatment fluid, in particular of the treatment gas. The axial end 34 of the nozzle 26 is preferably chamfered to facilitate the rupture of the cover 31 and may be of a diameter slightly less than the portion of external wall 32 coming into contact with the seal 17. The external wall 32 of the nozzle 26 also comprises an extra thickness 35 between the axial end 34 and the cylindrical portion of this wall 32 coming into contact with the seal 17. This extra thickness 35 is preferably of frustoconical shape as shown tapering towards the end axial 34, and has a non-return shoulder connecting with the external wall 32, so that it can be introduced by force, by elastic deformation, through the orifice 14 and the seal 17, subsequently preventing any untimely axial dissociation of the nozzle 26 outside the seal 17 and the orifice 14 of distribution. The non-return shoulder may be in the form of a radial crown.

  The extra thickness 35 has a sufficiently large external diameter to make a hermetic contact with the seal 17 as soon as it comes into contact with this seal 17. After the passage of the extra thickness 35 beyond the seal 17, the wall external 32 ensures the sealing of the treatment fluid.

  In one embodiment, the axial end 34 of the nozzle 26 can also itself provide a seal with the seal 17.

  In another embodiment, the axial end 34 has a smaller diameter than the seal 17, so that the seal is obtained only from the moment when the additional thickness 35 comes into contact with the seal 17. This dimensioning nevertheless has the advantage of facilitating the rupture of the cover 31, and the introduction and initial centering of the nozzle 26 in the orifice 14 and the cavity 24.

  In this second embodiment, the axial length of the axial end 34 of the nozzle 26 is adapted (sufficiently small) so that the hermetic contact can be established between the additional thickness 35 or the external wall 32 of the nozzle 26, and the seal 17 during a first stroke of axial approximation and of introduction into the orifice 14, without this end 34 coming into contact with the wall of the actuation cavity 24, that is to say i.e. without opening the valve 10.

  However, the total axial length of the nozzle 26, and in particular of the external wall 32, is adapted so that in a second axial approximation stroke 5 beyond said first stroke (the seal is therefore established), the end 34 of the nozzle 26 comes into contact with the wall of the actuation cavity 24 to cause its displacement and the opening of the valve 10.

  It should be noted that the presence of the cover 31 also has the effect of forcing the user to exert an axial force well aligned with the axis of the valve 10 and 10 of sufficient value, so that the introduction maneuver from the nozzle 26 in the valve until it is actuated, takes place correctly, almost instantaneously and without risk of leakage.

  The axial end 34 then enters the actuation cavity 24 and makes it possible to push the valve 19 axially inwards 15 until the closing edge 20 of the valve 19 is detached from the seal 17 The shapes of the axial end 34 of the nozzle 26 and of the sealing cavity 24 are also adapted so that a passage of treatment fluid is possible between the chamfered end edge of the axial end 34 and the bottom. 28 of the cavity 24. Consequently, as can be seen in FIG. 3, when the nozzle 26 is introduced inside the valve 10 and the valve 19 is pushed axially, the treatment fluid in the pocket 1 1 can circulate around the valve 19 in the bore 18, between the seal 17 and the closure edge 20, between the cavity 24 and the axial end 34, then can penetrate inside the nozzle 26 for s '' later flow axially through fitting 6 towards the outside of the ca touch 3.

  The outlet valve 10 thus formed is therefore a valve resiliently axially outwardly in the closed position by the spring 21, and which can be manually pushed axially inwardly in view of its opening for the release of the treatment fluid. and this, thanks to the bifunctional nozzle 26 for ejecting the processing fluid and actuating the valve 10.

  The device 5 for sterilization by filtration is for example a device as marketed by the company MILLIPORE (Billerica, Massachusetts, USA) under the name MILLEX. Such a device 6 comprises a rigid hermetic closed casing 39 made of PVC containing a microfilter formed from a membrane, the pores of which have a dimension of the order of 0.2 μm, capable of retaining pathogenic microorganisms. This casing 39 has a fluid inlet 38 with a frustoconical connection 37 and a fluid outlet 40. The fluid outlet 40 forms a frustoconical connection compatible with its direct connection to the axial end 41 of the syringe 4. Preferably, the outlet of fluid 40 defines a female frustoconical connection with 10 locking by standardized screwing, in particular of the "Luer-Lok E)" type.

  The connection 6 of upstream hermetic connection comprises, opposite the bi-functional nozzle 26, a frustoconical connection 36 combined with the frustoconical connection 37 of the fluid inlet 38 of the device 5 for sterilization by filtration. Preferably, these frustoconical connections 36, 37 comply with the standards in force, in particular of the Luer type (W. Thus, in the case where the fluid inlet 38 of the device 5 for sterilization by filtration is of the male connection type, the connector 6 includes a frustoconical female connection 36. This is the case of the embodiment shown. It is understood that it is equally possible to provide that the device 5 for sterilization by filtration be provided with an inlet 38 for fluid with female frustoconical connection, and the connector 6 then comprises a conjugated male frustoconical connection The frustoconical connection 36 of the connector 6 and that 37 of the fluid inlet 38 of the filtration sterilization device 5 can be either of the locking type by screwing (in particular of the so-called "Luer - Lok" type), or on the contrary of the non-locking type, the hermetic connection between them being obtained by simple relative fitting.

  The administration syringe 4 is a standard disposable syringe with a volume of between 10 ml and 100 ml, for example 50 ml. This syringe 4 comprises a piston 42 and a syringe body 43 defining a cylinder 44 in which the piston 42 can slide freely. The cylinder 44 opens into the axial end 41 emerging from the syringe body 43. In the example shown, this axial end 41 forms a standard frustoconical male connection with locking of the "Luer-Lok (") type. This axial end 41 is suitable to be able to receive the needle 7 which is itself provided with a female frustoconical connection with standardized locking 5, in a traditional manner. The needle 7 is itself packed in a closed pocket 45 and can be inserted inside of the syringe body 43 in a recess in the piston operating rod 42 as shown in FIG. 1.

  The bracelet 8 is adapted to be able to be placed around the wrist of the treated patient and this, for a double purpose. First of all, this bracelet 8 allows the nursing staff to know immediately that the patient has undergone a treatment by administration of fluid, in particular gas. Caregivers can therefore avoid subsequent errors in care and take the necessary precautions for the patient thus treated.

  Indeed, for example, certain therapeutic precautions must be taken with patients who have undergone a treatment by administration of gas in order to avoid any accident. In addition, the bracelet 8 can be provided with a label 46 which contains identification information of the cartridge 3 of treatment fluid used carried by this cartridge 3. Other similar labels can also be provided to be associated with the patient's medical record. In this way, perfect "traceability" of the treatment fluid is ensured.

  An example of a method according to the invention for using the device according to the invention is shown in Figures 4 to 8, respectively. First of all, the external envelope 2 is opened after having verified that the sterilization conditions have indeed been maintained (the external envelope 2 can be conventionally provided with colored indicators for guaranteeing the sterile state). The valve 10 of the cartridge 3 is then assembled axially to the syringe 4 provided with the device 5 for sterilization by filtration and the device 6 for hermetic connection upstream, so as to establish between them a communication hermetically isolated from the outside.

  It should be noted that, for the sake of clarity, the syringe 4, the sterilization device 5 and the upstream hermetic connection device 6 are shown separately in FIG. 1. However, in practice, these three elements 4, 5, 6 are preferably previously assembled to each other before packaging in the envelope 2. In this way, to carry out said hermetic communication, it suffices to join the device 6 for upstream hermetic connection (already secured to the device 5 and the syringe 4) and the valve 10 of the cartridge 3.

  The syringe 4 and the cartridge 3 are then brought together axially so as to open the valve 10 and to release the treatment fluid from the cartridge 3 which flows into the syringe 4, the piston 42 of which is spontaneously pushed back outside the body syringe 43 by the pressure of treatment fluid thus introduced inside the cylinder 44. The introduction of the individual quantity of treatment fluid into the syringe 4 therefore occurs by balancing the pressures as we approach the syringe 4 of cartridge 3.

  The cartridge 3 is then dissociated from the syringe 4. Preferably, the connector 6 of the valve 10 of the cartridge 3 is disconnected, for example by performing alternating angular movements in succession while exerting axial traction, so as to bring out the nozzle 26 (and the extra thickness 35) from the orifice 14. The presence of the nozzle 26 not compatible with the needle 7 prevents any subsequent accidental mounting of this needle 7 before the separation of the sterilization device 5 by syringe filtration 4.

  In the case where the treatment fluid is a gas, it is then possible, if necessary, to dilute the gas with atmospheric air by ejecting the excess gas from the cylinder 44 and by sucking inside this cylinder 44 a amount of atmospheric dilution air, via the sterilization device 5 by filtration. These two stages corresponding to the dilution are not necessary, in particular in the case where the treatment fluid is used in the pure state. The device 5 for sterilization by filtration is then dissociated from the syringe 4 and the needle 7 is quickly connected to the axial end 41 of the syringe. The syringe thus obtained represented in FIG. 8 is ready to use for administration to the patient.

  It should be noted that after the stage of filling the cylinder of the syringe 4, it is always possible to reinject part of the treatment fluid into the cartridge 3 by acting on the piston 42, via the hermetic communication thus produced. In doing so, the frustoconical excess thickness 35 of the nozzle 26 prevents any untimely dissociation of the cartridge 3 relative to the connector 6. It is even possible to reinject into the cartridge 3 all of the treatment fluid and to repeat the operation filling, in the event that the latter would not have taken place in a manner considered to be correct.

  The entire device according to the invention after packaging can be sterilized with ethylene oxide in the traditional way, at low cost and with high reliability. The presence of the cover 31 makes it possible to avoid any penetration of ethylene oxide inside the valve 10 and in contact with the treatment fluid. The device 1 then comes in a whole packaged in one piece, sterile ready for use.

  The invention can be the subject of numerous variant embodiments with respect to the embodiment described above and represented in the figures. For example, the cartridge 3 can contain only a pressure treatment gas (without separation pocket). The bifunctional nozzle can be directly formed by the inlet of the filtration sterilization device 5. The cover 20 31 can be produced so as to have a recess for guiding the nozzle opposite the orifice 14. The various frustoconical connections can be replaced in whole or in part by any other form of tight connection to the treatment fluid. (glued cylindrical assembly, joint assembly ...).

Claims (23)

  1 / Device for the extemporaneous preparation of an individual quantity of sterile treatment fluid for administration to a patient, comprising: - a reservoir (3) containing an amount of treatment fluid, - a syringe (4) for administration a dose of treatment fluid, comprising a piston (42) sliding in a cylinder (44) provided with an axial end (41) opening out, - a device (5, 6) for connection / sterilization adapted to allow the assembly and hermetic connection of the reservoir (3), the syringe (4) and the sterilization device (5) for filling the syringe (4), this connection / sterilization device (5, 6) comprising a device (5) sterilization by filtration comprising a sealed housing (39) provided with a fluid inlet (38), and a fluid outlet (40) delivering sterile fluid to the syringe (4), this housing (39) containing a filter capable of sterilizing the treatment flowing between the inlet (38) and the outlet (40), characterized in that: - the reservoir (3) consists of a rigid cartridge (3) 20 containing an individual quantity of pressurized treatment fluid , provided with an outlet valve (10) resiliently axially outwardly in the closed position and capable of being pushed axially inwardly in order to open it for the release of the treatment fluid, - the cylinder (44 ) of the syringe (4) is adapted to be able to contain the quantity of treatment fluid which can be released by the cartridge (3) at atmospheric pressure.   2 / Device according to claim 1, characterized in that the device (5, 6) for connection / sterilization is adapted to perform an axial assembly of the syringe (4), of this device (5, 6) for connection / sterilization, and the valve (10) of the cartridge, and to allow filling of the syringe (4), without leakage of treatment fluid, by simple axial bringing together of the syringe (4) and the cartridge (3).   3 / Device according to claim 2, characterized in that the device (5, 6) for connection / sterilization comprises a portion (26) for connection to the valve (10) of the cartridge (3), and in that this portion (26) of connection and this valve (10) are adapted so that: in a first stroke of relative axial approximation, a hermetic connection can be made between them, without actuation of the valve (10) of the cartridge (3) which remains closed, - in a second subsequent axial approximation stroke beyond the first stroke, the valve (10) is open.   4 / Device according to claim 3, characterized in that: - the valve (10) of the cartridge (3) is a female valve provided with an orifice (14) for distribution, with a seal (17) peripheral d sealing, and an actuating cavity (24) adapted to receive one end (24) of a bi-functional nozzle (26) for actuating the valve (10) and for ejecting the treatment fluid, - Said connection portion (26) of the connection / sterilization device (5, 6) forms a bi-functional nozzle (26) compatible with the female valve (10) of the cartridge (3).   5 / Device according to claim 4, characterized in that the device (5, 6) connection / sterilization comprises a device (6) hermetic upstream connection having, on one side, said nozzle (26) bifunctional compatible with the valve (10) female of the cartridge (3), and on the other side, a connection (36) compatible with the inlet (38) of the device (5) for sterilization by filtration.   6 / Device according to claim 5, characterized in that said connection (36) of the device (6) of upstream hermetic connection is a frustoconical connection combined with a frustoconical connection (37) formed by the inlet of the device (5) of sterilization by filtration.   7 / Device according to one of claims 1 or 6, characterized in that the outlet (40) of the device (5) for sterilization by filtration is adapted to be able to be connected directly to the axial end (41) of the syringe ( 4) administration.   8 / Device according to one of claims 1 to 7, characterized in that the outlet (40) of the device (5) for sterilization by filtration is a female frustoconical connection combined with a male frustoconical connection formed by the axial end ( 1) of the administration syringe (4).   9 / Device according to claim 4 and one of claims 10 1 to 8, characterized in that said nozzle (26) bi-functional comprises an outer wall (32) at least substantially cylindrical having an extra thickness (35) of elastic blocking extending in peripheral radial projection relative to this external wall (32) and adapted to elastically disappear when the seal (17) peripheral seal of the valve (10) of the cartridge (3) passes.   10 / Device according to claim 9, characterized in that the additional thickness (35) is adapted to prevent any untimely dissociation of the nozzle (26) relative to the valve (10), in particular during filling of the syringe (4 ).   11 / Device according to one of claims 9 or 10, characterized in that the additional thickness (35) is of generally frustoconical shape.   12 / Device according to one of claims 1 to 11, characterized in that the cartridge (3) comprises a flexible internal pocket (11) containing said individual quantity of pressurized treatment fluid connected to the outlet valve (10), and outside the pocket (11), an amount of pusher gas suitable for pressurizing the treatment fluid contained in the pocket (11).   13 / Apparatus according to claim 12, characterized in that the pusher gas is a physiologically acceptable gas.   14 / Device according to one of claims 12 or 13, characterized in that the pusher gas is of the same nature as the treatment fluid.   15 / Device according to one of claims 12 to 14, characterized in that the amount of pusher gas is adapted to maintain in the pocket (11) an overpressure of treatment fluid less than 2000 hPa in particular of the order of 600 to 1800 hPa-.   16 / Device according to one of claims 1 to 15, characterized in that the cartridge (3) comprises a volume of treatment fluid between lOmI and 100ml - in particular of the order of 40m1-.   17 / Apparatus according to claim 4 and one of claims 1 to 16, characterized in that the cartridge (3) comprises a seal (31) of hermetic closure of the orifice (14) of the valve (10) female adapted to prevent any penetration of sterilization fluid into the valve (10) and the cartridge (3), and to be able to be broken by introducing the bi-functional nozzle (26) into the orifice (14) of the valve ( 10).   18 / Device according to one of claims 1 to 17, characterized in that it comprises a sterile needle (7) capable of being connected to the end (41) of the syringe (4) for the administration of the fluid patient treatment.   19 / Device according to one of claims 1 to 18, characterized in that it comprises a label (46) -in particular in the form of bracelet (8) intended to be associated with the patient.   20 / Device according to one of claims 1 to 19, characterized in that it comprises an envelope (2) external sterile packaging containing all of the elements (3, 4, 5, 6, 7, 8) constituting of the device in a sterile state.   21 / Method for extemporaneous preparation of an individual quantity of sterile treatment fluid for administration to a patient, characterized in that: - a device (1) according to one of claims 1 to 20 is used, - the syringe (4), the connection / sterilization device (5, 6), the valve (10) of the cartridge (3) are assembled axially, so as to establish a communication hermetically isolated from the outside, - then the syringe (4) and the cartridge (3) 5 are brought together axially so as to open the valve (10) and to introduce into the syringe (4) a predetermined dose of sterile treatment fluid, by balancing the pressures.   22 / A method according to claim 21, characterized in that the treatment fluid is diluted in the syringe (4).   23 / Method according to one of claims 21 or 22, characterized 10 in that the device (5) for sterilization by filtration is then dissociated from the syringe (4) to which a needle (7) for administration is connected.